Tryngolza (olezarsen) — Highmark
familial chylomicronemia syndrome (FCS)
Initial criteria
- age ≥ 18 years
- diagnosis of FCS confirmed by either:
- 1. genetic test demonstrating biallelic pathogenic variants in at least one gene causing FCS (LPL, GPIHBP1, APOA5, APOC2, or LMF1) OR
- 2. genetic test results inconclusive AND member meets one of the following: FCS score ≥ 10 OR NAFCS score ≥ 45 OR history of pancreatitis OR history of eruptive xanthomas OR history of lipemia retinalis
- fasting triglyceride level ≥ 880 mg/dL
- Tryngolza will be used in combination with diet
Reauthorization criteria
- documentation of improvement in triglycerides from baseline
Approval duration
initial 6 months, reauthorization 12 months